Acupuncture

PEP Topic

Sleep-Wake Disturbances

Description

Acupuncture is a method of producing analgesia or altering the function of a body system by inserting fine, wire-thin needles (about the diameter of a strand of hair) into acupoints along a specific meridian (meridians are channels in the body that transport energy) on the body. The needles are twirled or energized electronically or are warmed and left in place for approximately 20 to 30 minutes. The acupuncture point P6 is most commonly used for the treatment of nausea and vomiting. Acupuncture has been evaluated in anxiety, chemotherapy-induced nausea and vomiting (CINV), dyspnea, pain, hot flashes, depression, lymphedema, sleep-wake disturbance, peripheral neuropathy, and fatigue.

Study Purpose:

To determine the effect of acupuncture on hot flash (HF) frequency and intensity, quality of life, and sleep quality in patients undergoing hormonal therapy for prostate cancer.

Intervention Characteristics/Basic Study Process:

Men with HF scores greater than four who received androgen-depriving therapy underwent acupuncture with electrostimulation biweekly for four weeks then weekly for six weeks using a predefined treatment plan. Patients completed a Hot Flash Diary daily for seven days prior to treatment then daily throughout the study.

Sample Characteristics:

The sample was comprised of 22 males with prostate cancer.

Median age was 71 years.

Patients were undergoing androgen deprivation therapy.

The study enrolled men with prostate cancer who were treated with bilateral orchiectomy, gonadotropin-releasing hormone agonist, or antagonists with or without antiandrogen therapy. The sample group reported at least four HFs per day. They could not be receiving concurrent chemotherapy, estrogens, progesteronal agents, or gabepentin. They had to be off of selective serotonin reuptake inhibitor (SSRI) class antidepressants for at least two weeks; however, the SSRI prohibition was removed after 16 patients were enrolled to speed accrual. Patients with pacemakers or other electrical devices were excluded.

Setting:

Single site

Outpatient

Sweden

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

The study has clinical applicability for late effects and survivorship and elderly care.

Study Design:

The study used an open-label, single arm, phase II design.

Measurement Instruments/Methods:

Hot Flash Related Daily Interference Scale (HFDIS)

Pittsburgh Sleep Quality Index (PSQI)

Short Form 36-item Health Survey (SF-36)

Blood samples plasma calcitonin gene-related peptide (CGRP)

Urine samples 5-HIAA

Hot Flash Diary

Results:

Acupuncture treatment was administered twice weekly, with an attempt to use the same practitioner throughout the treatment period. Specific acupuncture sites were used in all patients. The HF score was calculated from the Hot Flash Diary, and each HF was calculated to determine severity. The severity-adjusted HF scores were summed for seven days. Biomarkers were assessed at baseline; 2, 4, 6, and 10 weeks of treatment; and again after 6 weeks. The mean HF score was reduced after four weeks of therapy, then reduced to 52% of baseline at eight weeks. The HFDISs were available for 21 of the improved patients. The PSQI was available for 19 patients, but there was no statistical significance noted from baseline to after 10 weeks of treatment. No improvement in overall vitality was measured by the SF-36. No significant adverse effects were noted. Regarding the biomarkers, no change in the serum serotonin levels was noted for any patient. Urinary 5-HIAA had a nonsignificant trend toward reduced 5-HIAA concentrations, with the nonresponders (two patients) having an increase over time. The nonresponders' 5-HIAA concentrations were 129% of baseline, whereas the responders at week 10 showed 73.3% of baseline concentrations. The CGRP levels baseline sample results were so diverse that subsequent samples obtained during and posttreatment detected no meaningful differences. The variability in the CGRP samples reduced the statistical power of the study to detect differences.

Conclusions:

The study suggested that acupuncture may be an active nonpharmacologic option for patients with prostate cancer experiencing HFs while undergoing hormonal treatment.

Limitations:

The study had a small sample size, with less than 30 patients.

Hot flash Diaries were incomplete beyond week 8, so the severity of hot flashes was not calculable past the time point proposed.

The variability in the CGRP samples reduced the statistical power of the study to detect differences.

Nursing Implications:

Further research is needed in the use of acupuncture in reducing HF scores and improving sleep quality in prostate cancer survivors. Further research may also be needed to determine if differences exist between genders for HF distress/occurrence and sleep quality, which may provide some direction for extrapolating research results with either gender group.

Study Purpose:

To investigate the therapeutic effect of acupuncture on hot flashes and disturbed sleep in patients with breast cancer, the possible side effects of this treatment, and the effect on plasma estradiol levels

Intervention Characteristics/Basic Study Process:

Two experienced acupuncturists provided either true acupuncture or sham acupuncture in the predetermined points. Group 1 had manual acupuncture in pre-determined bilateral points for 15–20 minutes once a week for five consecutive weeks. These points were Hc6, Ki3, Sp6, and Lr3, which are located on the wrist, ankle, and foot. Group 2 had sham acupuncture in four predetermined bilateral non-acupuncture points outside the meridian but within the same region as the true points. The treatment was given once a week for five weeks. Group 3 received no acupuncture. All groups completed a log book. Plasma estradiol levels were measured in blood samples obtained just prior to the first treatment and 30 minutes after. It was measured again at five weeks later and 30 minutes after the final treatment. Group 3 had plasma estradiol levels obtained at allocation and five weeks later.

Results:

The researchers reported that a significant relief occurred in the acupuncture group after the second treatment, lasting until 6 weeks post-treatment (p < 0.05), as compared to the sham acupuncture and no treatment groups, which lasted for at least 12 weeks. A decrease in sleep disturbance also was noted in the same group as compared to the others. Side effects were reported as mild and temporary. Reported side effects included fatigue, pruritus, and nausea. No effect on the plasma estradiol levels in all groups occurred. Eleven women from all groups reported using concurrent treatments including clonidine and/or venlafaxine, mirtazapine with clonidine, and hormone replacement.

Conclusions:

The acupuncture group reported a decrease in hot flashes versus the other groups. No formal validation of the visual analog scale occurred. The concurrent use of other therapies may influence the reported outcomes. Restrictions of concurrent therapies for hot flashes during participation and validation of the self-reporting tool were needed.

Limitations:

Small sample (< 100)

Baseline sample/group differences of import

Unintended interventions or applicable interventions not described that would influence results

Other limitations/explanation: 11 participants used other forms of treatment in conjunction with their study participation to control hot flashes. Participants were Caucasian. No other groups were included in the sample.

Nursing Implications:

A large randomized trial exploring acupuncture versus placebo is needed that restricts concurrent therapy usage during trial participation and includes women with breast cancer having similar hot flash interventions such as tamoxifen or aromatase inhibitors with hot flash occurrence. True acupuncture may benefit, but further study is indicated.

Intervention Characteristics/Basic Study Process:

Women with a diagnosis of breast cancer receiving tamoxifen who reported experiencing HF&NS for more than three months underwent eight sessions of TA, delivered once weekly. They were monitored for 30 weeks, during which there were five measurement points. Data were collected using a paper-based hot flash diary. Physical and emotional well-being were measured using two questionnaires: the Women’s Health Questionnaire (WHQ) and the Hot Flashes and Night Sweats Questionnaire (HFNSQ).

Sample Characteristics:

The sample was comprised of 47 female patients.

Mean age was 54.3 years (range 37–68).

Patients

Were women taking tamoxifen as adjuvant treatment for early breast cancer

Were six or more months postsurgery, chemotherapy, or radiotherapy

Were taking tamoxifen for at least six months

Reported HF&NS for at least 3 months.

Had no recurrent or metastatic disease

Could be receiving concomitant preparations for relieving HF&NS, whether prescription or over the counter, if they had been taking them at least three months and would continue them through the trial period.

Setting:

Single site

Outpatient

Mount Vernon Hospital, Middlesex, United Kingdom

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

The study has clinical applicability for late effects and survivorship.

Study Design:

This was a prospective, single-arm, observational study using before and after measurements.

Conclusions:

The study supports using TA to manage HF&NS in women receiving tamoxifen as a breast cancer treatment. In addition, it suggests that the women received the added benefit of improved emotional and physical well-being with few side effects.

Limitations:

The study lacked an appropriate control group.

The study lacked control over the therapeutic relationship that was established between the practitioner and the patient, which could have contributed to the placebo effect.

Concomitant medication was used for managing hot flashes.

Nursing Implications:

Nurses should recognize that tamoxifen continues to pose distressing side effects in women with breast cancer, even after prolonged use. This study suggests that, through the use of TA, women receiving tamoxifen may be able to control some of these distressing side effects. Randomized, controlled trials using larger samples are warranted to validate TA as a tool for reducing these common side effects. Future studies, if including concomitant medications for hot flash symptoms, may want to control the types of concomitant medication usage for further analysis of results or have a randomized group to TA alone to TA plus a specific concomitant medication to note if hot flash symptoms are further controlled.

Study Purpose:

To study the effect of acupuncture on depression and insomnia in patients with malignant tumors.

Intervention Characteristics/Basic Study Process:

One time per day for 20 to 30 minutes, over a course of 30 days, patients in the intervention group received acupuncture on these acupoints: Fenglon (ST-40), Yinlingquan (SP-9), Xuehai (SP-10), Sanyinjiao (SP-6), Yintant (EX-HN3), Baihui (DU-20), Sishencong (EX-HN1), Neiguan (PC-6), and Shenmen (TF-4). Patients in the control group received fluoxetine, 20 mg/day. Depression scores and sleep ratings were collected before and after the three-day treatment.

Sample Characteristics:

The sample was comprised of 80 patients (66% male, 34% female) with malignant tumors: 40 patients were in the treatment group, which received acupuncture, and 40 were in the control group, which received 20 mg of fluoxetine daily.

All patients had a malignant tumor. Seven types of cancer were represented in the sample: lung, gastric, breast, colorectal, lymphoma, cervical, and ovarian cancer.

Depression was assessed according to the Chinese Classification of Mental Disorders, third edition (CCMD-3).

Patients with a functional disorder of the heart, liver, kidney, or spinal cord were excluded, as were those currently taking antidepressant medications.

Setting:

Single site

Beijing, China

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

The study was a randomized, controlled trial with intervention and control groups.

Measurement Instruments/Methods:

Zung Self-Rating Depression Scale (SDS)

Hamilton Rating Scale for Depression (HRSD)

Pittsburgh Sleep Quality Index (PSQI)

Results:

Pretreatment SDS scores of the treatment and control groups were 64.12 (SD = 5.34) and 64.24 (SD = 4.98), respectively, with no significant difference (p > 0.05). After treatment, SDS scores of the treatment and control groups were 43.64 (SD = 5.28) and 50.76 (SD = 5.42), which showed significant difference (p < 0.05). HRSD scores of both groups showed no significant difference before treatment (p > 0.05); however, after-treatment scores were 9.88 (SD = 1.27) in the treatment group and 13.72 (SD = 2.05) in the control group (p < 0.05). These results indicate that both acupuncture and fluoxetine were effective in reducing depression scores in these patients, with acupuncture showing greater effectiveness. PSQI scores of the treatment group, before and after treatment, were 14.48 (SD = 1.71) and 7.92 (SD = 1.22), respectively, with a significant difference (p < 0.001). The control group's PSQI scores, 13.92 (SD = 2.59) and 11.44 (SD = 1.89), did not reach significance (p > 0.05). Results indicate that acupuncture improved sleep quality in more patients than did fluoxetine.

Conclusions:

Both acupuncture and fluoxetine were associated with reduced depression scores and some improvement in sleep. Due to the lack of a real control group and no control over cancer type and treatment phase, drawing a conclusion about the effectiveness of the intervention is difficult.

Limitations:

The study had a small sample size, with less than 100 patients.

The age range was small.

The study was conducted at a single site, and the measurement tools were self-report instruments.

Fluoxetine may take more than 30 days to reach therapeutic effectiveness.

The study compared a fluoxetine-using group to an acupuncture-using group; the study included no real control group.

The sample included diverse cancer types, and patients were at different phases of treatment. These factors may confound the findings.

The authors did not analyze the differences between groups in regard to posttreatment PSQI scores.

The study did not include an attentional control or consider the possible placebo effect of acupuncture.

Nursing Implications:

Acupuncture is a nonpharmacologic intervention that shows promise in reducing depression and improving sleep quality in patients with cancer and depression.

Results:

Ten breast cancer survivors (BSCs) completed baseline, and two withdrew after the last baseline assessment. The remaining eight BSCs completed all time points. There was no significant difference among acupuncture points used per patient for the three treatments or the four providers. Sessions were mainly conducted at a single clinic. The study described patients as having high outcome expectations for acupuncture effectiveness and its acceptability. Sleep patterns were affected: sleep latency increased and time spent awake after sleep onset decreased. The average number of HFs decreased.

Conclusions:

Expectations for and credibility and acceptability of acupuncture in managing vasomotor and sleep symptoms were high for the BSCs.The study demonstrated minimal improvement in total sleep time and some sleep latency improvement immediately following completion of acupuncture sessions but not at week 8 (not a sustainable effect); waking after sleep onset improved.

Limitations:

The study had a small sample size, with less than 30 patients.

The majority of the patients enrolled were not taking a hormone modulator at the time of enrollment; therefore, the authors were unable to extrapolate the results found here to apply to BSCs using aromatase inhibitors or tamoxifen in treating their breast cancer.

The number of acupuncture treatments was limited to three over two weeks.

Reproducible results were limited because the study mainly occurred at one site with one acupuncturist.

No control group was used for comparison to the intervention of acupuncture.

Nursing Implications:

The study showed that women may be amenable, especially highly motivated women, to pursuing acupuncture as a nonpharmacological approach to managing HFs. Further investigations with larger sample sizes are needed to note if there are any correlations with socioeconomic/cultural influences for the acceptability of acupuncture and to compare acupuncture to another intervention for the control of HFs/sleep quality.

Fatigue: Three RCTs met the criteria for analysis. All had high risks of bias, and two had negative outcomes.

Hot Flashes: Seven RCTs met the criteria for analysis. None had a low risk of bias.

Anxiety or Depression: Five of the six RCTs analyzed showed positive results. All five had high risks of bias.

Sleep: Three RCTs met the criteria for analysis, and all three reported positive outcomes and had high risks of bias.

Conclusions:

The strongest evidence that the study produced showed that acupuncture may be effective for the management of CINV. The study did not show acupuncture to be efficacious in the treatment of other symptoms.

Limitations:

The studies included were of low quality.

Nursing Implications:

Available evidence, which was limited, did not support the claim that acupuncture is effective in alleviating various adverse symptoms in adults with cancer. Additional research is needed to determine the efficacy. The findings of this analysis suggested that patients with uncontrolled CINV may be appropriate candidates for acupuncture referral. For the treatment of other symptoms, the efficacy is undetermined.

Search Strategy:

INCLUSION CRITERIA: ​Studies in adults using acupuncture in which at least one of the outcomes was reported as a primary or secondary study outcome

EXCLUSION CRITERIA: Pediatric patients and review articles

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: Not reported

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Standards for reporting interventions in clinical trials of acupuncture guidelines were used, but there were no specific methods of study quality evaluation overall.

Sample Characteristics:

FINAL NUMBER STUDIES INCLUDED = 12

TOTAL PATIENTS INCLUDED IN REVIEW = 923

SAMPLE RANGE ACROSS STUDIES: 10–302 patients

KEY SAMPLE CHARACTERISTICS: Studies included perioperative use and patients in hospice care; most of the studies were of patients with breast cancer and breast cancer survivors.

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Elder care

Results:

The studies included 11 quantitative and one qualitative study. Their findings showed positive effects on sleep in two studies, one of which was a single-arm, nonrandomized study. Positive effects were shown on anxiety in three studies, one of which was single-arm. Four studies showed positive effects on depression, one of which was single-arm. Five studies did not show acupuncture to have any effects. It was noted that acupuncture methodology was inconsistently reported. There also was a lack of data such as standard deviations and change scores.

Conclusions:

This review showed mixed results for the effects of acupuncture on sleep, depression, and anxiety. The current evidence has several study design and reporting limitations.